Drug recall: Cardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles (NDC 0187-0795-30); and b) 90-count…

Class III FDA enforcement event 82021. Recall start date: 30 Jan 2019. Status in the FDA record: Terminated. Termination date: 8 Jul 2020.

Reason for recall, in the words of FDA

Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

Class III, in the words of FDA

a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences

Valeant Pharmaceuticals North America LLC started this drug recall on 30 Jan 2019. The firm address in the FDA record is in Bridgewater, NJ. FDA put the recall in Class III. FDA event 82021 has 5 product records. The first FDA enforcement report date is 20 Feb 2019. The record gives the status Terminated, with the termination date 8 Jul 2020.

FDA enforcement report The 5 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide in the USA and Puerto Rico

Recalling firm

Valeant Pharmaceuticals North America LLC, Bridgewater, NJ.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

5 product records in the event.

FDA event 82021: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0487-2019	Cardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles (NDC 0187-0795-30); and b) 90-count bottles (NDC 0187-0795-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada.	1023 bottles	Class III	Terminated	20 Feb 2019
D-0488-2019	Cardizem CD (diltiazem HCl) capsules, 180 mg, packaged in a) 30-count bottles (NDC 0187-0796-30); and b) 90-count bottles (NDC 0187-0796-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada.	206 bottles	Class III	Terminated	20 Feb 2019
D-0489-2019	Cardizem CD (diltiazem HCl) capsules, 240 mg, packaged in a) 30-count bottles (NDC 0187-0797-30); and b) 90-count bottles (NDC 0187-0797-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada.	390 bottles	Class III	Terminated	20 Feb 2019
D-0490-2019	Cardizem CD (diltiazem HCl) capsules, 300 mg, packaged in a) 30-count bottles (NDC 0187-0798-30); and b) 90-count bottles (NDC 0187-0798-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada.	22 bottles	Class III	Terminated	20 Feb 2019
D-0491-2019	Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; NDC 68682-521-01.	23,884 bottles	Class III	Terminated	20 Feb 2019

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class III: The lowest of the three FDA recall classes.

The event in context

Drug events that started in 2019: 362
Share of these events in Class III: 22%
Product records in this event: 5Median of the firm: 1
Events of the firm on the register: 14

Other events of the firm

Other FDA enforcement events of Valeant Pharmaceuticals North America LLC
Initiated	Product (first record)	Type	Class	Records
24 Aug 2018	Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) spray bottle, OTC, Distributed by: Valeant	Drug	Class II	3
10 Jul 2018	Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal delivery systems with lubricating	Drug	Class III	1
28 Jun 2017	Obagi-C Rx System C-Therapy Night Cream, Net wt. 2 oz. (57g) bottle, Rx only, Distributed by OMP, Inc., Long Beach, CA M	Drug	Class III	1
20 Mar 2017	CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment 5 fl. oz. (148 mL), Valeant Pharmaceuticals North America	Drug	Class III	2
10 Jun 2016	SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles, Rx Only. Distributed by: Valeant Pharmaceut	Drug	Class III	1
23 May 2016	Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsules, 60-count bottles, Distributed by: Valea	Drug	Class III	1
14 Sep 2015	Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Aerosol Generator SPAG-2 6000 is a pneumatic	Device	Class II	1
4 Sep 2015	Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only. Distributed by: Santarus, Inc. San Diego, CA 921	Drug	Class II	1
18 Apr 2015	Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100-count bottle, Rx Only, Manufactured in Can	Drug	Class III	2
17 Apr 2015	Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals USA	Drug	Class II	1

Valeant Pharmaceuticals North America LLC: all 14 events

Official channels

FDA enforcement report D-0487-2019The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 82021. https://recallregister.com/fda/iii/82021/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide in the USA and Puerto Rico
What quantity of product is in FDA event 82021?: The event has 5 product records. The first record gives this quantity: 1023 bottles
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2019 have the same class?: 22% of the 362 drug events that started in 2019 are in Class III.